Nutrition, Growth and Development Among Very Preterm Infants
- Conditions
- Low Birth Weight Infant
- Registration Number
- NCT01103219
- Lead Sponsor
- University of Oslo
- Brief Summary
The main purpose of this study is to evaluate the effect of increased supply of energy, protein, vitamin A and the long chain polyunsaturated fatty acids docosahexaenoic acid and arachidonic acid on growth, brain maturation and cognitive function.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 50
- Birth weight below 1,500 grams
- Written consent to participate from the parents
- Congenital malformations
- Clinical syndromes known to affect growth and development
- Critical illness and short life expectancy
- If participants refuse to participate
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Reduction in discharge rate of small-for-gestational age very low birth weight infants 6 months corrected age The primary endpoint is to reduce the discharge rate of very low birth weight infants that are small-for-gestational age, from 60 to 40%.
- Secondary Outcome Measures
Name Time Method Evaluation of brain function and growth of infant 6 months corrected age Secondary endpoints will include:
1. Assessment of brain maturation using MRI.
2. Cognitive measurements.
3. Anthropometric measures and biomarkers to assess body growth and development.
4. Morbidity- (e.g. ROP, BPD, PVL, NEC) and mortality rates.
Trial Locations
- Locations (3)
Akershus University Hospital
🇳🇴Nordbyhagen, Norway
Oslo University Hospital, Rikshospitalet
🇳🇴Oslo, Norway
Oslo University Hospital, Ullevaal
🇳🇴Oslo, Norway
Akershus University Hospital🇳🇴Nordbyhagen, Norway